In Mallinckrodt Hospital Prods. IP Ltd. v. Praxair Distrib., Inc., Judge Sleet of the U.S. District Court for the District of Delaware invalidated personalized method of treatment claims under 35 USC § 101 as being directed to a natural phenomenon. If the Federal Circuit affirms the decision, will it leave room to draw a line that spares other methods of treatment?
In Novartis v. Lee (Fed. Cir. 2014), the Federal Circuit agreed with the USPTO that “time spent in a continued examination” does not count towards the three years the USPTO is allotted to examine a patent before if it must award Patent Term Adjustment (PTA) for “B” delay. Under the USPTO’s rules, filing a Request for Continued Examination (RCE) stops that PTA clock, but in Ariad Pharmaceuticals, Inc. v. Matal, the U.S. District Court for the Eastern District of Virginia found that the clock should keep running when the USPTO mishandles an RCE. So, exactly when does an RCE stop the PTA clock?
We’ve written previously about ex parte decisions of the Patent Trial and Appeal Board (PTAB) affirming patent eligibility rejections that seem to be inconsistent with the USPTO’s Subject Matter Eligibility Guidance. Apparently, applicants should be wary about appealing any rejection of a diagnostic method claim, because the PTAB may enter sua sponte patent eligibility rejections even if the examiner did not make a § 101 rejection. Continue reading this entry
In Genzyme Corp. v. Dr. Reddy’s Labs. Ltd., the Federal Circuit affirmed the district court decision upholding Genzyme’s Orange Book listed patent for the cancer drug Mozobil® against an obviousness challenge, because the asserted prior art references failed to provide a reasonable expectation of success. While a non-precedential decision, this case illustrates the important role that unpredictability in the art and a lack of expectation of success can play in biotechnology patents.
A few weeks ago I joined Kathleen Fonda, Ph.D., J.D., Senior Legal Advisor in the USPTO’s Office of Patent Legal Administration, and Gary Ganzi, J.D., Senior Counsel and Head of Intellectual Property for Evoqua Water Technologies, on an IPO Chat Channel program on the use of Rule 130 declarations to disqualify prior art under the America Invents Act (AIA). Even though I played the role of outside counsel “expert” on the topic, there were a few things about Rule 130 declarations I had forgotten since I first studied the USPTO’s rules and guidelines 5 years ago.